FDA’s Follow-Up Sunscreen Trial Shows More Of The Same: Absorption Of All Tested UV Filters
Executive SummaryThe FDA emphasizes that findings from its second, more extensive clinical study on the absorption potential of sunscreen active ingredients are not in themselves signals that the UV filters are unsafe. However, they portend heavy work ahead for industry if the ingredients are to remain GRASE and available for use in OTC sunscreen drug products stateside.
You may also be interested in...
Industry advocates working to support GRASE determinations for eight UV filters are faced with a dilemma. They would like to share nonpublic studies with the FDA on a confidential basis – at least to get initial temperature readings from the agency as to the studies’ usefulness in addressing data gaps – but under the current OTC monograph framework, no such pathway exists.
The US FDA is still working through more than 20,000 comments on its February proposed rule to establish a final OTC sunscreen drug monograph. Thus, it will not meet the 26 November 2019 deadline set by the Sunscreen Innovation Act of 2014, said Theresa Michele, director of FDA’s nonprescription drug division, during a 21 November public meeting with industry advocates.
A National Toxicology Program rat study linking oxybenzone to “equivocal evidence of carcinogenic activity” is far from damning, but it's a reminder of just how steep a mountain industry may have to climb to maintain the UV filter’s generally recognized as safe and effective (GRASE) status for OTC marketability, currently under FDA review.